Expertise: Medical Device 33 results
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantables such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help...
Over the past decade, the development of digital medicines has been steadily gaining momentum, with real-world data demonstrating that these approaches can help improve patient lives. The COVID-19 pandemic further propelled the digital medicines industry forward by shining a light...
Medical Device
FAQs: In Vitro Diagnostic Medical Device Regulation
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for...
Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test...
Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and...
New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. By 2025, the global aesthetic medicine market is projected...
As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device...
The emerging markets of the APAC region offer tremendous potential for clinical research. Best practices for cardiovascular medical device development in Asian countries can offer insights on navigating the regulatory and clinical landscape of this region. Widely recognized as one...
For medical device developers seeking to enter the diverse, complex Asia-Pacific (APAC) market, having a well-planned reimbursement strategy is critical for commercial success. Thoughtful consideration of coverage, coding, and payment should be factored into the product development cycle at its...